Introduction to DNV Healthcare and NIAHO℠ A New Choice for Hospital Accreditation

1. Introduction to DNV Healthcare and NIAHO℠ A New Choice for Hospital Accreditation

2. DNV • Established in 1864 • Independent, self supporting Foundation • Tax paying entity (in every country it operates) • 300 Offices in 100 Countries • 9000 Employees (locally employed) • Operating in the U.S. since 1898 © Det Norske Veritas AS. All rights reserved

3. The DNV Purpose Safeguarding life, property and the environment © Det Norske Veritas AS. All rights reserved

4. The DNV Vision Global impact for a safe and sustainable future © Det Norske Veritas AS. All rights reserved

5. DNV Values We build trust and confidence We never compromise on quality or integrity We are committed to teamwork and innovation We care for our customers and each other © Det Norske Veritas AS. All rights reserved

6. Emergence of “Hospital Accreditation” • Hospital Accreditation – increased use of the term globally • An increasingly accepted term to denote a formal independent review to national regulations that carries with it a monetary return to the accredited organizations • Formal exclusive use in the US for the last 50 years • Other nations are adopting a similar approach • DNV’s Focus in Hospital Accreditation • Approved by the US Centers for Medicare & Medicaid Services (CMS) to deem hospitals in compliance with the Medicare Conditions of Participation for Hospitals (42 C.F.R. §482) • Also a a “Risk partner” to the UK National Healthcare Services (NHS) in assessing hospitals, developing standards and training hospital staff in enhancing patient care © Det Norske Veritas AS. All rights reserved

7. The need for DNV’s new accreditation alternative

8. Medical Errors/Adverse Events… • Evidence is present to indicate that medical errors are still occurring at an alarming rate despite current efforts to impact reduction • Fear of legal ramifications and other protections under the law have created reporting barriers for hospitals • Hospitals feel compelled to implement measures to address these events, yet are struggling with managing their effectiveness • Poorly designed and ineffective processes that lack consistency are the primary cause for these outcomes © Det Norske Veritas AS. All rights reserved

9. Lack of quality management system infrastructure • Processes in healthcare organizations are very complex and require a great deal of communication and validation to be effective. • Processes become more difficult to manage and control when they become more decentralized. • The improvement of quality, performance and outcomes is directly related to the accountability for the processes. • Hospitals struggle with introducing new methodologies to focus their efforts and abandon one methodology only to replace it with another producing the same results © Det Norske Veritas AS. All rights reserved

10. Other accreditation models…. • Limit the focus to primarily clinical settings and associated activities • Pay less attention to important non-clinical processes such as management and support processes that play a vital role in the overall effectiveness of the healthcare delivery system that impact quality • Represent only a snapshot of the hospital with a fair amount prepared just prior to the on-site visit, and does not represent standard operating procedure © Det Norske Veritas AS. All rights reserved

11. New Face for Hospital Accreditation © Det Norske Veritas AS. All rights reserved

12. DNV Healthcare Inc. NIAHOSM and ISO 9001 Quality Management System Hospital Accreditation: Integration of NIAHO℠ Standards with ISO 9001 Quality Management System Standards

13. Infrastructure and Accreditation CMS (CoPs) (Accreditation Oversight) NIAHO℠ Accreditation Requirements (Consistent with CMS CoPs - Requirement for ISO Compliance/Certification) ISO 9001:2000 Quality Management System (Infrastructure of QMS) © Det Norske Veritas AS. All rights reserved

14. Why NIAHO℠ • Meets and exceeds CoP requirements • Includes ISO 9001:2000 QMS (proven basis for continual improvement) • No additional staff required to implement NIAHO℠ • Annual visits – added accountability • Focus on sequence and interactions of processes throughout the hospital • Leads to improvement of patient safety and reduction in hospital’s internal cost of accreditation © Det Norske Veritas AS. All rights reserved

15. DNV Accreditation Progression • 1st visit: • Get Accredited to NIAHO℠ - meet the requirements of CMS • Get a gap analysis to ISO 9000 with the road map to achieving it within a maximum of 2 years • 2nd visit – 1 year after accreditation • Continue accreditation by undergoing an survey to NIAHO℠ • Survey for progress in implementing ISO 9001 • If in compliance with ISO 9001 – a statement included in Certificate of Accreditation • May choose to demonstrate compliance by obtaining a separate ISO 9001 certificate • 3rd visit – • Continue accreditation by undergoing survey to NIAHO℠ • Be in compliance with ISO 9001 © Det Norske Veritas AS. All rights reserved

16. Applying ISO 9001 QMS in Healthcare What can hospital gain from implementing ISO 9001? • Improve the quality “system” to reduce errors and improve performance • Improve the effectiveness and efficiency of processes that enable errors and are hindered with complexity • Increase patient satisfaction • Learn from and benefit from the success ISO 9001 QMS has produced in other sectors, especially the service industry © Det Norske Veritas AS. All rights reserved

17. Terminology … Quality Policy = Mission, Vision Quality Objectives = Organization’s Quality Goals & Objectives Corrective Action = CQI/PI Process – RCAs Preventive Action = FMEA Process Internal Audit = Review of departmental & organization processes and outcomes; individual performing cannot come from area being audited Document Control = Sundown provision Management Representative = Quality Director Management Review = Enlarged Quality Council Function © Det Norske Veritas AS. All rights reserved

18. Process Map Example © Det Norske Veritas AS. All rights reserved

19. Introduction of a New Accreditation Model Ensuring that Quality and Patient Safety is Managed, Not Just Measured!! © Det Norske Veritas AS. All rights reserved

20. Quality Management System Governing Body Chief Executive Officer Medical Staff Nursing Services Staffing Management Medication Management Surgical Services Anesthesia Services Laboratory Services Respiratory Care Services Medical Imaging Nuclear Medicine Services NIAHO℠ Standards - Chapters • Rehabilitation Services • Obstetric Services • Emergency Department • Outpatient Services • Dietary Services • Patient Rights • Infection Control • Medical Records Service • Discharge Planning • Utilization Review • Physical Environment • Organ, Eye and Tissue Procurement © Det Norske Veritas AS. All rights reserved

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22. 4.0 Quality Management System 4.1 4.2 5.0 Management responsibility 5.1 5.2 5.3 5.4 5.5 5.6 8.0 Measurement, analysis and improvement 6.1 6.2 6.3 6.4 CUSTOMER CUSTOMER 8.1 8.2 8.3 8.4 8.5 6.0 Resource management 7.0 Product realization 7.1 7.2 7.3 7.4 7.5 7.6 4.1 General 4.1.f Continual Improvement* 4.2 Document requirements 4.2.2 Quality Manual Justification & process flow diagram* 4.2.3 Documentation 4.2.4 Records 5.1 Management commitment (4.1) 5.2 Customer focus* 5.3 Quality Policy* 5.4 Planning (objectives) 5.5 Responsibility & authority 5.5.3 Internal Communication* 5.6 Management review 8.1 General 8.2 Monitor & measure 8.2.1 Customer Satisfaction* 8.2.2 Internal audit 8.2.3 Processes* 8.2.4 Product 8.3 Nonconforming product 8.4 Analysis of data * 8.5 Improvement 8.5.1 Continual* 8.5.2 Corrective 8.5.3 Preventive 6.1 Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work environment INPUT OUTPUT 7.1 Planning and product realization 7.2 Customer related 7.2.1 Determine requirements* 7.2.2 Review requirements 7.2.3 Customer requirements* 7.3 Design & development 7.4 Purchasing 7.5 Production 7.6 Calibration © Det Norske Veritas AS. All rights reserved

23. Crosswalk CoP – NIAHO℠ - ISO 9001 © Det Norske Veritas AS. All rights reserved

24. ISO 9001 As the Infrastructure for NIAHO℠ Accreditation • The inherent requirements for process improvement result in good outcomes specified in the CMS Conditions of Participation • Hospitals are held accountable through the mechanisms required in ISO 9001 for Internal Audits, Management Review and Corrective / Preventive Action • Allows hospital innovation to determine HOW assures sustainable and safe best practices that support this approach © Det Norske Veritas AS. All rights reserved

25. Implementation plan for ISO 9001:2000 © Det Norske Veritas AS. All rights reserved

26. NIAHO℠ Survey Activities

27. Survey Team Generalist Surveyor • Quality Management Review • Medication Management • Medical Staff and Human Resources Review • Ancillary / Support Services Review (Laboratory, Medical Imaging, Rehab, etc.) Clinical Surveyor • Operational Review Activities • Patient Care Unit Visits (Clinical Settings) • Med-Surg, ICU, CCU, Obstetrics, Emergency Department Physical Environment / Life Safety Specialist • Physical Environment aspects and review of management plans • Physical Environment / Life Safety Tour • Biomedical Engineering (Equipment) © Det Norske Veritas AS. All rights reserved

28. Conducting the Survey - Arrival • Survey team arrives on-site together • The team leader provides identification and the Announcement letter to the Receptionist at the information (front) desk and a request is made to contact the hospital representative • Hospital will typically request that the survey team sign-in and be provided with necessary identification as required by the hospital • The survey team is escorted to a conference room and makes preparations with the hospital representative to conduct the survey • A copy of the survey schedule is provided to the hospital representative to make the desired copies and assemble the appropriate parties for the opening meeting © Det Norske Veritas AS. All rights reserved

29. Opening Meeting • Explanation of the purpose, scope of the survey, and provide a schedule of survey activities to the organization (the schedule may be adjusted as necessary) • Brief explanation of the survey process; • Introduction of survey team members, • Clarification of all organization areas and locations, departments, and patient care settings under the hospital provider number and/or scope statement that will be surveyed, including any contracted patient care activities or patient services located on organization campuses or organization provider based locations • Discuss the location (e.g., conference room) where the team may meet privately during the survey • A telephone and internet connection for team communications (or access to these services if needed), preferably in the team meeting location • Determine how the facility will ensure that surveyors are able to obtain the photocopies of material, records, and other information as they are needed • Obtain the names, locations, and telephone numbers of key staff to whom questions should be addressed • Discuss the approximate time, location, and possible attendees of any meetings to be held during the survey • Discuss the proposed date and time for the Closing Meeting. • During the Opening Meeting, the Team Leader will request that the organization provide the survey team with the documents requested for Document Review as listed. © Det Norske Veritas AS. All rights reserved

30. Initial Survey Team Meeting & Document Review • Review the scope of hospital services • Identify hospital locations to be surveyed, including any off-site locations • Adjust surveyor assignments, as necessary, based on information provided • Discuss issues such as change of ownership, adverse events, construction activities, and disasters, if they have been reported • Make an initial patient sample selection (The patient list may not be available immediately after the opening meeting and the team may delay completing the initial patient sample selection a few hours as meets the needs of the survey team) – this is reviewed during the document review session Document Review List © Det Norske Veritas AS. All rights reserved

31. Conducting Survey Activities Survey activities are carried out through as follows: • A comprehensive review includes observation of care/services provided to the patient, patient and/or family interview(s), staff interview(s), and medical record review. • Using Tracer methodology, department/patient unit audits to include staff interviews and open medical record review as appropriate (both clinical and support departments) • identify performance issues • handoff between steps • Tracer methodology has been in place with ISO 9001 long before it was adopted by any accreditation organization. © Det Norske Veritas AS. All rights reserved

32. Conducting Survey Activities Surveyors will pay particular attention to the following: • Patient care, including treatments and therapies in all patient care settings; • Staff member activities, equipment, documentation, building structure, sounds and smells; • People, care, activities, processes, documentation, policies, equipment, etc., • Integration of all services to determine that the facility is functioning as one integrated whole • Whether quality improvement is a organization-wide activity, incorporating every service and activity of the organization • Interaction between various hospitals departments and activity reports to assure quality management oversight, facilitating the organization-wide quality management system. • Awareness and the effectiveness of the hospital’s quality management system • Storage, security and confidentiality of medical records. © Det Norske Veritas AS. All rights reserved

33. Conducting Survey Activities Review documentation (written and electronic) and include the following: • Patient’s clinical records and its validation by interviews • Plans of care and discharge plans, review of the pre-surgical assessment, informed consent, operative report, and pre-, inter-, and post-operative anaesthesia notes. • Personnel files, competency/performance assessments, and licenses (as required) • Physician and allied health credential files • Maintenance and calibration records to determine if equipment is periodically attested and/or calibrated to determine if it is in good working order and if environmental requirements have been met • Staffing documents to determine if adequate numbers of staff are provided • Policy and Procedure Manuals • Contracts, if applicable • Organization activities minutes as requested © Det Norske Veritas AS. All rights reserved

34. Closing Meeting • The Team Leader is responsible for organization of the presentation of the exit. • The facility determines which hospital staff will attend the closing meeting. • The Team Leader will explain how the team will conduct the closing meeting and any associated ground rules. • The surveyor will present the findings of Nonconformity, explaining why the finding is a non-compliance issue. • The team will assure that all findings are discussed at the closing conference. © Det Norske Veritas AS. All rights reserved

35. Post-Survey Activities • An oral report of the findings will be provided by the Survey Team at the closing meeting of each survey and provide the opportunity for the organization to discuss any of the findings prior to survey team ending the survey. • The Team Leader will submit the Preliminary Report to DNVHC offices after the survey has concluded. • DNVHC will forward the Final Survey Report to the organization within 10 days of the last date of the survey. © Det Norske Veritas AS. All rights reserved

36. Nonconformities Handling Classification of FindingsThe surveyor shall categorize the findings to: Nonconformity (NC)- (Category 1) • Objective evidence exists that a requirement has not been addressed (intent), a practice differs from the defined system (implementation), or the system is not effective (effectiveness). • The absence of one or more required system elements or a situation which raises significant doubt that the services will meet specified requirements. • A group of category 2 non-conformities indicating inadequate implementation or effectiveness of the system relevant to requirement of the standard. • A category 2 non-conformity that is persistent (or not corrected as agreed by the customer) shall be up-graded to category 1, OR a situation, that, on the basis of available objective evidence, would have the capability to cause patient harm or does not meet a standard of care. • Condition Level Finding- A Condition Level Finding is a Category 1 Nonconformity in which the customer is determined to be completely or substantially out of compliance with the standard. Such finding is made on a case-by-case basis in DNV Healthcare Inc.’s sole discretion. A Condition Level Finding will be identified as a Category 1 Nonconformity- Condition Level Finding. All Condition Level Findings will require a follow-up survey prior to the next annual survey. © Det Norske Veritas AS. All rights reserved

37. Nonconformities Handling Nonconformity (NC)- (Category 2) • A lapse of either discipline or control during the implementation of system/procedural requirements, which does not indicate a system breakdown or raise doubt that services will meet requirements. Overall system requirement is defined, implemented and effective. • As applicable a finding as a Category 2 nonconformity may be: • An isolated non-fulfillment of a standard requirement that is otherwise properly documented and implemented, or, • Inconsistent practice compared to other areas of the customer, or, • Significant enough to warrant the customer to take action to prevent future occurrence and/or has the potential for becoming a Category 1 nonconformity. © Det Norske Veritas AS. All rights reserved

38. NIAHO℠ Report and Corrective Action Submittal • Using the NIAHO℠ Report Template – The findings are noted according the findings categories • The NIAHO℠ Standard Number, • Description • Applicable Standard Requirement (SR statement), • Applicable Interpretive Guidelines for clarification (if necessary) • For the Physical Environment – related LSC Code and other appropriate codes may be indicated • Finding statement (stating of applicable objective evidence) © Det Norske Veritas AS. All rights reserved

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40. Organization Response – Corrective Action • The organization is required to respond with the Corrective Action Plan(s) to address any nonconformities and/or observations to DNVHC • Example of Corrective Action Submittal Form – Response • A review is conducted for acceptance and approval of the corrective action plan(s) and noted on the form. • Once the corrective action plans have been accepted and approved, a copy of the survey schedule, NIAHO℠ Report and Corrective Action Response is submitted for review by members of the Accreditation Committee with a Accreditation Committee Action Form © Det Norske Veritas AS. All rights reserved

41. Accreditation Committee Review/Decision • There are a minimum of two accreditation committee members required to approve/deny accreditation of an organization based on review of the documentation • The members reviewing the report packages will have the following qualifications: • Knowledge of processes/functions within the hospital setting • Experience in a leadership and/or clinical role within the hospital setting • Knowledge of the NIAHO℠ Standards and Accreditation Process • Knowledge of the ISO 9001 QMS Requirements It is not necessary that each member have all qualifications but all requirements listed above must be covered by the members conducting the review. © Det Norske Veritas AS. All rights reserved

42. Accreditation Committee Review/Decision • If the Accreditation Committee approves the issuance of an Accreditation Certificate, the Executive Vice President of Accreditation or designee will verify all appropriate information and approvals and will print the certificates and send it to the Accredited Organization. • If the Accreditation Committee does not approve the issuance of an Accreditation Certificate, the reasons must be documented in writing and sent to the affected hospital. © Det Norske Veritas AS. All rights reserved

43. Appeal Process • Appeals received by DNV Healthcare Inc. shall be: • Registered in a log to record the progress to completion; • Acknowledged by DNV Healthcare Inc. without undue delay; and, Reviewed and answered. • The appeal is not bound to a particular form or content. However, the appeal shall be submitted in writing stating the basis of the appeal and the relief being requested. The appeal can be faxed, e-mailed or sent by US mail to: Darrel J. Scott, Senior Vice President, Regulatory & Legal Affairs DNV Healthcare Inc. 463 Ohio Pike, Suite 203 Cincinnati, Ohio 45255 Fax: (513) 947-1250 Email: Darrel.Scott@dnv.com © Det Norske Veritas AS. All rights reserved

44. Appeal Process • The appellant shall be informed of the right to: • Present its case in person. • Appeal to the President of DNV Healthcare Inc. if the appellant does not accept the decision of the Executive Vice President, Accreditation. • The following applies for all appeals: • The decision reached by the Executive Vice President, Accreditation or President shall be communicated to the appellant in writing • If the appellant still remains dissatisfied with the decision of the Executive Vice President, Accreditation or President, the appellant is entitled to one (1) appeal to the Standards and Appeals Board. The appeal will be conducted in accordance with the Standards and Appeals Board Procedures in Appeals. • Any appellant notice that it will pursue a remedy beyond DNV Healthcare Inc. shall be reported to DNV Corporate Legal Affairs through the Vice President, Regulatory Affairs. • Corrective ActionThe Executive Vice President of Accreditation and President, if appropriate, shall review the final outcome of all appeals to determine the need for any change in DNV Healthcare Inc. procedures. © Det Norske Veritas AS. All rights reserved

45. Certificate Issuance • Upon conformation that any nonconformities noted have been corrected and closed • Upon approval of the Accreditation Committee, the NIAHO℠ Accreditation Certificate is created and issued to the hospital. • Example of a NIAHO℠ Accreditation Certificate © Det Norske Veritas AS. All rights reserved

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47. Infrastructure and Accreditation Improved patient care and safety CMS (CoPs) (Accreditation Oversight) NIAHO℠ Accreditation Requirements (Consistent with CMS CoPs - Requirement for ISO Compliance/Certification) ISO 9001:2000 Quality Management System (Infrastructure of QMS) Hospital Patient Care Processes and Supporting Operations © Det Norske Veritas AS. All rights reserved

48. Question & Answer Session © Det Norske Veritas AS. All rights reserved

49. Yehuda Dror, President Yehuda.Dror@dnv.com www.dnvaccreditation.com © Det Norske Veritas AS. All rights reserved